PRIME II is a natural successor to PRIME I, with similar eligibility criteria (see below). Patients are randomised to receive or not receive adjuvant radiotherapy, following breast conserving surgery and endocrine therapy. The recruitment target is 1300 patients, with a projected closure date of 30th November 2009.

The principal endpoints for this second phase of the trial are ipsilateral breast recurrence rates, regional recurrence rates, contralateral recurrence, distant metastases, disease-free survival, and overall survival.

Currently, there are 95 centres participating in the trial, including centres from Greece, Belgrade, Yugoslavia, and Malta, and two from Australia. For a complete list of participating centres, please click here.

Graph of recruitment by centre Recruitment is well underway, with 1270 randomised directly into PRIME II. Following Ethics approval and further funding from the Scottish Government and the Breast Cancer Institute, our new target for patients recruited directly into PRIME II is 1306. Graph of recruitment by time

Inclusion criteria
  1. Breast conserving surgery with an excision margin of a minimum of 1mm on histological assessment
  2. Histologically confirmed unilateral breast cancer of pathological size 3cm or less
  3. Oestrogen receptor or progesterone receptor positive and treated with adjuvant endocrine therapy (including pre-operative neo-adjuvant endocrine therapy)
  4. No axillary node involvement on histological assessment
  5. Medically suitable to attend for all treatment and follow up
  6. Able and willing to give informed consent
Exclusion criteria
  1. Age younger than 65 years (at the time of pathology results)
  2. Grade III cancer combined with lymphatic/vascular invasion (because of higher risk of local recurrence)
  3. Previous in situ or invasive carcinoma of either breast
  4. Current or previous malignancy within the past five years, other than non-melanomatous skin cancer or carcinoma in situ of cervix

A copy of the protocol in Adobe Acrobat format can be found here. If you would prefer a paper copy, please contact the Trial Administrator. Copies of the documentation and Site Specific Assessment forms can be found on the downloads page.

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This page was written by Dr Linda Williams and last updated on 1st October 2009.